Edwards PASCAL System: Transcatheter mitral valve repair with the Edwards PASCAL System
Abbott Mitraclip System: Transcatheter mitral valve repair with the Abbott Mitraclip System
Study summary
To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in patients with functional mitral regurgitation (FMR) on guideline directed medical therapy (GDMT)
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Eighteen (18) years of age or older
* Patient is able and willing to give informed consent and follow protocol procedures, and comply with follow-up visit requirements.
* Patient is determined to be at prohibitive risk for mitral valve surgery by the heart team (CLASP IID cohort only).
* Patient is on stable heart failure medications/Guideline Directed Medical Therapy (CLASP IIF cohort only)
* Patient is determined to be a candidate for transcatheter mitral valve repair by the heart team for both PASCAL and MitraClip
* Mitral regurgitation (3+ to 4+) by echo
* Suitable valve and regurgitant jet morphology
* Elevated corrected BNP \> 400 pg/ml or corrected NT-pro BNP of \> 900 pg/ml or heart failure hospitalization within the past 12 months (CLASP IIF cohort only)
* LVEF ≥ 20% (and ≤ 50%; CLASP IIF cohort only)
Exclusion Criteria:
* Patient in whom a TEE is contraindicated or screening TEE is unsuccessful
* Mitral valve anatomy which may preclude proper PASCAL or MitraClip access, use and/or deployment or sufficient reduction in mitral regurgitation
* Patient with refractory heart failure requiring advanced intervention (i.e. left ventricular assist device, Status ≤5 heart transplantation) (ACC/AHA Stage D heart failure)
* Clinically significant, untreated coronary artery disease
* Recent stroke
* Other severe valve disorders requiring intervention
* Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months
* Any prior mitral valve surgery or transcatheter mitral valve procedure (excluding chordal replacement or surgical annuloplasty repair)
* Severe tricuspid regurgitation or tricuspid valve disease requiring surgery
* Active rheumatic heart disease or rheumatic etiology for MR
* Severe aortic stenosis or regurgitation
* Known history of untreated, severe carotid stenosis
* Recent deep vein thrombosis (DVT) or pulmonary embolism (PE)
* Severe COPD
* Pregnant or planning pregnancy within next 12 months. Note: Female patients of childbearing potential need to have a negative pregnancy test performed within 14 days prior to intervention and be adherent to an accepted method of contraception
* Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator
* Patient is currently participating in another investigational biologic, drug or device clinical study where the primary study endpoint was not reached at time of enrollment
* Other medical, social, or psychological conditions that preclude appropriate consent and follow-up, including patients under guardianship
Primary outcome measure(s)
PASCAL is not inferior to MitraClip with respect to the proportion of patients with major adverse events (MAE). The primary safety endpoint is a composite of Major Adverse Events (MAEs). — 30 days.
PASCAL is not inferior to Mitraclip with respect to the proportion of patients with MR severity reduction as measured by echocardiography using a scale of 0-4+ for the CLASP IID Cohort. — 6 months
PASCAL is not inferior to Mitraclip with respect to the time to first heart failure hospitalization or death for the CLASP IIF Cohort only. — From date of randomization until date of first heart failure hospitalization or death, through 5 year follow-up
Trial sites (81)
Facility
City
Region
Status
Banner University Medical Center
Phoenix
Arizona
TMC Healthcare
Tucson
Arizona
Scripps Memorial Hospital La Jolla
La Jolla
California
Cedars Sinai Medical Center
Los Angeles
California
UC Irvine
Orange
California
Sutter Medical Center-Sacramento
Sacramento
California
Kaiser Permanente San Francisco
San Francisco
California
University of California, San Francisco
San Francisco
California
Stanford University
Stanford
California
Los Robles Hospital and Medical Center
Thousand Oaks
California
Medical Center of the Rockies
Loveland
Colorado
Medstar Washington Hospital Center
Washington D.C.
District of Columbia
The Cardiac and Vascular Institute Research Foundation
Gainesville
Florida
Mount Sinai
Miami Beach
Florida
NCH Rooney Heart Institute
Naples
Florida
AdventHealth Orlando
Orlando
Florida
Piedmont Healthcare
Atlanta
Georgia
Emory University Hospital and Emory University Hospital Midtown
Atlanta
Georgia
Northwestern University
Chicago
Illinois
St. Vincent Heart Center
Carmel
Indiana
University of Iowa Hospitals & Clinics
Iowa City
Iowa
Massachusetts General Hospital
Boston
Massachusetts
Brigham and Woman's Hospital
Boston
Massachusetts
Beth Israel Deaconess Medical Center
Boston
Massachusetts
University of Michigan
Ann Arbor
Michigan
Henry Ford Hospital
Detroit
Michigan
Mayo Clinic
Rochester
Minnesota
St.Luke's Hospital of Kansas City
Kansas City
Missouri
Washington University/Barnes Jewish Hospital
St Louis
Missouri
Morristown Medical Center
Morristown
New Jersey
Rutgers-RWJMS
New Brunswick
New Jersey
Albany Medical College
Albany
New York
State University of New York at Buffalo
Buffalo
New York
NYU Langone Hospital - Long Island
Mineola
New York
NYU Langone Health
New York
New York
Columbia University Medical Center/New York Presbyterian Hospital
New York
New York
Lenox Hill Hospital and North Shore University
New York
New York
Rochester General Hospital
Rochester
New York
Montefiore Medical Center
The Bronx
New York
The Christ Hospital
Cincinnati
Ohio
+ 41 more sites — see the full list on the official registry below.
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.